MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XP180N

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history of this device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the instrument channel of the subject device tested positive for microbes (7cfu/100ml).The type of microbes are unknown.This device had been reprocessed using an olympus automated endoscope reprocessor model etd3 (not available in the usa) with peracetic acid.The user facility reported that this device was reprocessed according to the instruction manual.There was no report of patient infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent this device to a third party laboratory for additional microbiological testing.As a result of additional microbiological testing, the following results were obtained.Therefore, it cleared the french guideline.Total channel: 2 cfu/100ml (micrococcaceae).Instrument channel: no microbe.Suction channel: no microbe.Air/water channel : 5 cfu/100ml (micrococcaceae).The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7145285
• MDR Text Key: 96219243
• Report Number: 8010047-2017-02070
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP180N
• Other Device ID Number: 04953170339097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1